DиаDЭНС® ПКМ (стр.

2–88)

«TRONITEK» LLC, Ekaterinburg, Russia

DiaDENS PCM
®

DiaDENS® PCM (s.174–261)

CONTENTS
Part 1. Technical Passport
1. Safety regulation.......................................................94
2. Purpose.......................................................................98
3. Specifications............................................................99
4. Complete set...........................................................109
5. Device assembly.....................................................110
6. Recommendations
on use of the device............................................115
7. Using the menu......................................................117
8. Technical maintenance........................................139
9. Batteries replacement.........................................140
10. Troubleshooting list...........................................141
11. Manufacturer’s warranty..................................145
Part 2. Usage instruction
1. General provisions.................................................150
2. Indications and contraindications
for use............................................................................151
3. Conditions for treatment....................................153
4. Intensity (power) of electrostimulation.........154
5. Modalities..................................................................157
6. Treatment with the device.................................159
Appendix 1. Used accessories..................................263
Appendix 2. Scheme of «Express» menu...............275
Warranty certificate..................................................301
Acceptance certificate................................................304
Thank you for purchasing of the device DiaDENS-PCM.
In order to make the usage of the unit effective and safe, please, carefully read all sections
of this manual.
92
 PART 1
Technical Passport

93
 1. SAFETY REGULATIONS
Information contained in present operations manual is important for
your safety and proper use and maintenance of the device.

The device is safe for use due to its bult-in low voltage electric power sourse
isolated from the operation part of the device (article of type B with body of type F).

The device must not be used for treatment of patients with implanted electronic
devices (for example, pacemakers) and for treatment of patients with individual
electric current intolerance.
Use of the device in direct front projection of heart is prohibited.

94
Don’t treat patient with any high-frequency electric device during stimulation;
simultaneous use of the device and other electric equipment can cause burns
and lead to possible damage of the device.

Work near short-wave and microwave equipment can bring to instability of

output parameters of the device.

You must not connect to the device any other accessories except remote
electrodes produced by manufacturing company.

The device contains fragile components. Protect it from shocks.

95
 The device is not waterproof. Protect it from ingress of moisture.

All works on maintenance and repair of the device must be executed by qualified
specialists of the manufacturer.

Transport conditions: temperature from -50OC to +50OC, relative air humidity

from 30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg).

Storage conditions: temperature from -50OC to +40OC, relative air humidity from
30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg.).

96
Operation conditions: temperature from +10OC to +35OC, relative air humidity
from 30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg).

Attention! If the device has been stored at the temperature below 10OC keep it in
normal climate conditions for no less than 2 hours - before use.

Utilization: All packaging materials are not environmentally harmful, they may be
used repeatedly.

Separate collection of electrical and electronic equipment.

The device contains valuable materials which can be used repeatedly after utilization
with consideration of requirements of environmental protection. They shall be
delivered to specially intended for this purpose places (consult with corresponding
services in your district) for collection and processing. 97
 2. PURPOSE
Universal transcutaneous electrostimulator DiaDENS-PCM is intended for application
of system-regulating impact on physiological systems of the body and for the treatment
of functional disorders under wide range of diseases. Dynamic electroneurostimulation is
executed through impulses of electric current on biologically active points and zones of the
human body. The device provides possibility of selection of individual treatment program as
well as already prepared for use programs. The device has a built-in electrodes and a socket
for connection of remote therapeutic electrodes *.
The device DiaDENS-PCM is intended for use in health care facilities and in home conditions
in accordance with the instructions of a physician.
Compliance with standards: This medical device is CE marked according to the
Directive 93/42 /ЕЕС on medical equipment.

98 You can only connect to the device those remote electrodes which are produced by the company-manufacturer (see Appendix 1).
3. SPECIFICATIONS
3.1. Electric impulse of the device have following output parameters:
3.1.1. Without load:
— amplitude of 1st phase (V) < 40;
— length of 1st phase (uS) - 22 ± 25%;
— amplitude of 2nd phase (V) - 72 ± 25%.
Comments: parameters of impulse do not change under adjustment of power and
frequency.
3.1.2. With load = 20 kOhm
Minimum Maximum
Power (in nominal units)
1 99
Amplitude of 1st phase, V ≤ 40 ≤ 40
Length of 1st phase, uS 6 ± 25% 530 ± 25%
Amplitude of 2nd phase, V 9 ± 25% 300 ± 25% 99
 3.1.3. Dependence of impulse form from load resistance at average and maximum
power levels.
Power level 50 units Power level 99 units
Load resistance
Form of current Vp-p Form of current Vp-p

Without ≈110 V ± ≈110 V ±

load 20 % 20 %

≈12 V ± ≈12 V ±
200 Ohm
20 % 20 %

100
 ≈29 V ±
≈30 V ±
20%
20 %
Ieff =16
500 Ohm Ieff = 17 mА
mA
Epulse≈205
Epulse≈110
uJ
uJ

≈52 V ± ≈60 V ±
1 kOhm
20 % 20 %

≈90 V ± ≈100 V ±
2 kOhm
20 % 20 %

101
 ≈282 V ± ≈300 V ±
10 kOhm
20 % 20 %

≈310 V ± ≈330 V ±
20 kOhm
20 % 20 %

3.2. The device provides possibility of setting of following frequencies of impulses, Hz:
3.2.1. Range 1:
— 10±1, including modes «Experess», MED (prophylaxis) and 14 «Screening»;
102
 — 20±1; 60±2; 77±2; 140±3; 200±3;
— 77±2 and 10±1 modulated by frequency 2±0,1 (mode «77 10»);
— 77±2 with modulation by amplitude (mode «77AM»).
3.2.2. Range 2: from 1,0 to 9,9 with increment 0,1±0,05.
3.3. Maximum current consumption (under supply voltage of 3 V - no more than 300 mA.
3.4. Electrical power supply: batteries of type LR6/AA, 2 pcs., with voltage 1,5±0,45 V. It is
allowed to use corresponding accumulator batteries with nominal current of 1,2 V*.
3.5. Mass of the device is no more than 0,35 kg.
3.6. Dimensions of the device are no more than 165х65х65 mm.

Operations procedure (types of battery rechargers, methods of recharge) are described in instructions manual
for accumulator batteries. Running time of the device under use of accumulators depends on characteristics of
accumulators. 103
 3.7. The device automatically switches off not later than in 10 min after the last touch of any
of its buttons (except button ) or after the last contact of the electrodes with patient’ skin
surface.
3.8. Electromagnetic emission
Test Compliance with IEC 60601-1-2 Terms of use
RD radiation Electrosimulator DiaDENS-PCM is suitable for
Class B
CISPR 11 use in health care facilities and at home

3.9. Resistance to RF-radiation

Test IEC 60601-1-2 test conditions Acceptable level
IEC 61000-4-6 3 Vrms from 150 kHz to 80 mHZ 3 Vrms
IEC 61000-4-3 3 V/m from 80 MHz to 2,5 GHz 3 V/m
104
3.10. Resistance to electromagnetic fields
Level of
Test Test level Terms of use
compliance

Electrostatic Floor should be made of wood, concrete, or

±6 kV ±4 kV
discharge ceramic tiles. If floor is covered with synthetic
contact ±8 contact ±8
(ESD) IEC material the relative humidity should be at least
kV impact kV impact
61000-4-2 40%.

Magnetic Parameters of magnetic fields should be at

fields 3 A/m 3 A/m levels typical for commercial or health care
IEC 610004-8 buildings

105
 3.11. Recommendations on determination of required distance between electrostimulator
DiaDENS-PCM and radio equipment
Radiated frequency and formula for
Rated maximum output power of determination of distance d (m)
Transmitter P (W) 150 khz - 80 MHz 150 khz - 800 MHz 800 MHz - 2,5 HHZ
d = 1,2VP d = 1,2VP d = 2,3VP
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
3.12. Terms of use
3.12.1. Connection of remote electrodes not allowed by manufacturer (including
change of length of cable, type of cable, construction of electrode) can lead to increase
of electromagnetic radiation level and/or decrease of device resistance to external
106 impacts.
3.12.2. The device DiaDENS-PCM uses electromagnetic energy only for internal
functions, and due to this fact, radiation of the device is minimal and shall not impact
nearest electronic equipment. The device DiaDENS-PCM shall not be used alongside
other equipment. If such action is deemed necessary then DiaDENS-PCM and other
equipment shall be checked for correctness of operation under joint use.
3.12.3. The device DiaDENS-PCM is intended for work in specific conditions of
electromagnetic environment, and the customer (user) shall check if these conditions
comply with required values.
Electrostatic discharge (ESD). Floor should be made from wood, concrete or ceramic tiles.
If floor is covered with synthetic material. Then relative air humidity shall be no less than
40%.
RF-radiation. Portable and mobile devices shall be used near any part of the device
DiaDENS-PCM at the distance of no less than d = 2,3 V P (800 MHz + 2,5 HHz), where P –
is maximum output power according to manufacturer’s information.
107
 3.12.4. Recommended user activities
Electrostatic discharge (ESD). The user shall not use clothes made of synthetic materials.
RF radiation. The personnel (user) shall take following safety measures: minimal
distance to portable means of communication (cellular phones, cordless phones) shall
be approximately 3 meters in case when output power of the devices exceeds 2 W.

108
4. COMPLETE SET
Item Quantity
Electrostimulator DiaDENS-PCM 1
Operations manual 1
Consumer container 1
Battery 2

109
 5. DEVICE ASSEMBLY Fig. 1. The device DiaDENS-PCM
(top view)
6 7 8 1. Body.
2. Socket for connection of remote
electrodes (closed with cover).
3. Display.
4. Keyboard.
5. Button for selection of menu
item .
6. Button of return to previous
menu item .
7. Button of return to main menu
.
8. Buttons for navigation in device’s
menu .
1 2 3 4 5 9 9. On/Off button.

110
1 2 Fig. 2. The device DiaDENS-PCM
(bottom view)
1. Cover of battery compartment.
2. Built-in electrode.

111
 You can connect to the device remote therapeutic electrodes of models produced by
manufacturer (see Appendix 1).

Attention! Remote therapeutic electrodes can be used only in modes «Express» or

«Therapy».

Before use of remote electrode in order to improve contact you can moister the skin in area
of impact.

112
5.1. Appearance of display in different modes
5.1.1. Symbols of main menu of the device
Treatment
Battery charge
Settings Volume
Timer
Day timer
Current time

5.1.2. Symbols of menu «Treatment»

«Therapy» mode
«Express» mode
MED mode «Screening» mode
113
 5.1.3. Items of menu «Settings»

Battery preservation
Display settings
Storage of last used
settings
Sound settings

5.1.4. Items of menu «Day timer»

Time and date setting

Alarm settings

114
6. RECOMMENDATIONS ON USE OF THE DEVICE
6.1. Switching the device on
Press button . After the sound signal and logo the device goes to statuses:
— main menu if function «Storage of last used settings» has been switched off (p.8 of the
table);
— to the mode in which the device has been switched off if function «Storage of last used
settings» has been switched on.
6.2. Selection of mode or function
Using navigation buttons select required mode, function or value, press button to open
them.
6.3. Return to menu
To show the menu of above level, use button . To return to main menu of the device press
button .
115
 6.4. Switching the device off
Press button and hold it for approximately 3 seconds. On display will appear a message
«Good Health» and after sound signal and a message «Good bye» the device will switch off.

116
7. USING THE MENU
7.1. Structure of the menu
Treatment
Express
Back Joints Head Hypertension Hypotonia Trauma Cold Throat Cough Nausea Inflation Diarrhea Constipation
Тherapy
10 Hz 20 Hz 60 Hz 77 Hz 140 Hz 200 Hz 7710 77АМ 9,9 Hz ... 0,1 Hz
Main МED
menu Screening
Settings
Display Sound Battery Storage of last
economy used settings
Brightness Contrast General Contact Buttons
Organizer
Clock Alarm
Date Time On/Off Time Repeat
117
 7.2. Selection of menu item
1. Menu «Express»

With the help of navigation buttons select in menu «Treatment»

1.1 section «Express» and confirm your choice by pressing the
button

In this section find required mode of operation/disease with

1.2
buttons and . Make a selection and press button

118
 The device will start select mode of operation, meanwhile,
power of the device will be set to minimal level. Readjust power
1.3 with buttons and .
Methods of operation in mode «Express» are described in detail
in «Usage instruction», part 2

2. Menu «Therapy»

With the help of navigation buttons select in menu «Treatment»

2.1 section «Therapy» and confirm your choice by pressing the
button

119
 2.2 In this section find required frequency of impact with buttons
and , make a selection and press button

In case of selection of infra-low frequency the device will present

you the menu of infra-low frequency adjustment. With the help
2.2.1
of navigation buttons select required frequency (first integral
part, then – decimal) and press button to confirm your choice.

120
 The device will start chosen mode of operation, meanwhile,
power of electrostimulation of the device will be set to minimal
2.3 level. Readjust power with buttons and .
Methods of operation in mode «Therapy» are described in detail
in «Usage instruction », part 2

3. Minimum effective dose (MED)

With the help of navigation buttons select in menu «Treatment»

3.1 section «MED» and confirm your choice by pressing the button

121
 The device will show mode MED, meanwhile, power of the
device will be set to minimal level. Readjust power with buttons
3.2 and .
Methods of operation in mode «MED» are described in detail in
«Usage instruction», part 2

4. Diagnostics mode «Screening»

With the help of navigation buttons select in menu «Treatment»

4.1 section «Screening» and confirm your choice by pressing the
button

122
 The device will show mode «Screening», meanwhile, fixed power
of electrostimulation will be set for the purpose of safety.
4.2
Methods of operation in mode «Screening» are described in
detail in «Usage instruction », part 2

5. Menu «display settings»

With the help of buttons and select in menu «Settings»

5.1 item «display» and confirm your choice by pressing the button

123
 The device will show mode «Display settings»: adjustment of
brightness and contrast. With the help of buttons and
5.2
select one of adjustabile parameters and confirm your choice by
pressing the button

Adjustment of display brightness: the device provided 5 levels of

brightness of display from minimal (1st level of brightness)
to maximal (5th level of brightness) which can be selected by
5.2.1 pressing buttons and .
Attention! Increase of brightness leads to increase of current
consumption and early replacement of batteries. Use of minimal
level of brightness will allow to use batteries for a long time.
124
 Adjustment of display contrast: the device provided 5 levels
of contrast of display from minimal (1st level of contrast) to
5.2.2
maximal (5th level of contrast) which can be selected by pressing
buttons and

6. Menu «sound settings»

6.1 With the help of buttons and in menu «Settings» select

item «Sound» and confirm your choice by pressing button

125
 The device will show the menu «Sound settings»: general sound
of the device, sound under contact with skin, sound under
6.2 pushing keyboard buttons. With the help of buttons and
select one of adjustabile parameters and confirm your choice by
pressing button

For adjustment of general sound of the device 3 sound levels

are provided: mute, minimum and maximum indicated by digits
0.1 and 2 correspondingly. With the help of buttons and
select one of sound levels and confirm your choice by pressing
6.2.1 button .

Attention! Sound signals are generated with consideration of

specified sound level. Under selected sound level «mute», sound
signals will not be generated.
126
 Setting of sound signal under contact with skin: contact of
electrodes with skin can be confirmed by sound signal. With
6.2.2
the help of buttons and switch this function on or off and
confirm your choice by pressing button

Menu navigation can be accompanied by sound signals. With

6.2.3 the help of buttons and switch this function on or off and
confirm your choice by pressing button

127
 7. Menu «Economy battery»

7.1 With the help of buttons and in menu «Settings» select

item «Economy» and confirm your choice by pressing button

The device will show the menu «Economy Battery» which allows
to change status of function «Economy Battery»: go to mode
of reduced energy consumption at the expense of switching
off highlighting (independent of selected brightness level) and
7.2 decrease of time of automatic switching off if the device is not used
to 1 minute. In addition, under switching on of function «Economy
Battery» function «Storage of last used settings» is switched on
automatically. With the help of buttons and switch this
function on or off and confirm your choice by pressing button
128
8. Menu «Storage of last used settings»

With the help of buttons and in menu «Settings» select

8.1 item «Storage of last used settings» and confirm your choice by
pressing button

The device will show the menu «Storage of last used settings».
This item allows to change status of function «storage of last
used settings». If function is switched on then the device will
8.2 switch on in mode in which it has been switched off. If the
function is switched off then the device will show main menu.
With the help of buttons and switch this function on or off
and confirm your choice by pressing button
129
 9. Menu of setting of date and time

9.1 With the help of buttons and in menu «Day timer» select
item «Clock» and confirm your choice by pressing button

The device will show menu of adjustment of time and date. With
9.2 the help of buttons and in menu select one of adjustabile
items and confirm your choice by pressing button

130
 Setting of date: the device allows to adjust current date, to do
so, with the help of buttons and select digit which you
9.2.1 want to adjust and press buttons and to change digits
according to actual value and confirm your choice by pressing
button

Setting of time: the device allows to adjust current time, to do

so, with the help of buttons and select digit which you
9.2.2 want to adjust and press buttons and to change digits
according to actual value and confirm your choice by pressing
button

131
 10. Menu of alarm settings

10.1 With the help of buttons and in menu «Day timer» select
item «Alarm» and confirm your choice by pressing button

The device will show menu of alarm settings: switching alarm

on and off, adjustment of time of alarm, adjustment of alarm
10.2 periodicity. With the help of buttons and in menu select
one of adjustabile items and confirm your choice by pressing
button

132
 Switching alarm on and off: this item allows to change status
of function «Alarm». If function is switched on the device will
emit sound signal at the time and in the period specified by
10.2.1 user. For termination of sound signal it’s necessary to switch
on the device with button . With the help of buttons and
switch this function on or off and confirm your choice by
pressing button

Setting of alarm time: for adjustment of time with the help of

buttons and select required area and with buttons and
10.2.2
change digits according to required value and confirm your
choice by pressing button

133
 Adjustment of alarm periodicity: with the help of buttons and
10.2.3 select one of variants of periodicity — single, daily, weekly
(1 time per week) and in working days. Confirm your choice by
pressing button

7.3. Menu of quick access

Some of settings of the device are available for user through menu of quick access. Symbols
of this menu are situated in bottom row of the display and menu of stimulation modes
(«Express», «Therapy»). Selection one of such symbols with the help of buttons , and
134
confirmation of choice by button shows to user menu of adjustment of one of these
parameters. To exit these menus press button after confirmation of parameter or button
to exit menu without storage of adjusted parameter.
Мenu «Тimer»

Function «Timer» is necessary in cases when it is impossible

to control time of impact (electrostimulation of hard-to-reach
places) or when time of stimulation is clearly specified. After
activation of this function time of stimulation will be counted
1. down. В In case when function is switched off maximum time
of one session is 30 minutes.
With the help of navigation buttons if you are in menu of
stimulation modes («Therapy»), select symbol of menu «Timer»
and confirm your choice by pressing button

135
 The device will show menu item «Timer». With the buttons
and set required time of timer – from 0 to 25 minutes
2 (discreteness – 5 minutes). In case of setting 0 minutes function
is considered switched off and in modes of stimulation time will
be counted in regular regime

Мenu «Volume level»

Menu «Volume level» provides possibility of quick access to

setting of general sound level of the device.
With the help of navigation buttons if you are in menu of
1
stimulation modes («Express», «Therapy», MED or «Screening»),
select symbol of menu «Volume level» and confirm your choice
by pressing button
136
 The device will show menu of adjustment of general sound level
- 3 sound levels are provided: mute, minimum and maximum
indicated by digits 0.1 and 2 correspondingly. With the help of
buttons and select one of sound levels and confirm your
2
choice by pressing button
Attention! Sound signals are generated with consideration of
specified sound level. Under selected sound level «Mute» sound
signals will not be generated

137
 Menu «Contact»
illuminated constantly –
Menu «Contact» provides possibility of management of function of forced therapy
function «Forced therapy» — formation of electrical impulses is switched off, or remote
independent of contact of electrodes with skin. Function electrodes are not connected;
«Forced therapy» is switched on automatically under connection
flashes – forced therapy
1 to device of remote electrodes and can be switched on at will in is switched on or remote
case of need (for example, for brittle treatment of zone). electrodes are connected;
With the help of navigation buttons if you are in menu of
stimulation modes («Express», «Therapy»), select symbol of absence of contact of built-in
electrodes with skin. Wet your
menu «Contact» and confirm your choice by pressing button skin slightly for contact.

The device will show menu «Contact». With the buttons and
2 switch this function on or off and confirm your choice by
pressing button
138
8. Technical Maintenance
8.1. Daily technical maintenance should include the following:
— external examination of the device;
— disinfection of electrodes.
For purposes of disinfection use standard disinfection means (such as 3% solution of
hydrogen peroxide) and soft napkins without nap to clean the electrodes.
8.2. Check of serviceability in accordance with instructions specified in Part 6.
8.3. If you will not use the device for a long period remove the power source from its
compartment (fig. 2).
8.4. If the battery symbol flashes on the display and there is a pulsing sound signal change
the battery (section 9).
Attention! If power source is absent for more than 10 seconds all individual settings
of the user, set reminders, information on current date and time will be deleted.
139
 9. BATTERIES REPLACEMENT
Replacement of power source:
— open battery compartment (1) and take the batteries out;
— install new batteries into the device* with consideration of polarity (2);
— close battery compartment (3).
1 2 3

Use only those batteries that are suitable for this device — type LR6/AA, voltage rating 1,5 V, or appropriate
140 accumulators with nominal voltage 1,2 V.
10. TROUBLESHOOTING LIST
Trouble Possible reason Method of elimination

Set new batteries (see section «Batteries

1) The device does not There are no batteries
replacement»)
switch on when you
press button Voltage of batteries is less Change batteries ( see section «Batteries
than 2,1 V replacement»)

Voltage of batteries is less Change batteries ( see section «Batteries

than 2,1 V replacement»)
2) Under switching on
the device emits sound Period of time between
signals and switches off switching on of the device Wait 3 seconds after switching off the
and its subsequent switching device and switch it on again
on is less than 3 seconds
141
 Mode of stimulation is not Go to menu «Express» or «Therapy» and
3) The device does not selected select required mode of stimulation
pass to status «Therapy»
Insufficient area of contact of Tightly apply built-in electrode to skin. If
under contact of built-
electrode with skin necessary slightly wet skin before contact
in electrodes with skin
Power level is zero Increase power level
4) The device does not
emit sound signals
(under switching on of Increase volume. Go to section Settings →
Sound is switched off
mode, change of power Sound → Volume
level, end of work and
so on)
Mode of stimulation is not Go to menu «Express» or «Therapy» and
5) The device does
selected select required mode of stimulation
not pass to status
Insufficient area of contact of Tightly apply remote electrode to skin. If
«Therapy» under use of
electrode with skin necessary slightly wet skin before contact
remote electrodes
Power level is zero Increase power level
142
 Function «Battery Switch off function «Battery preservation»
6) Highlighting of
preservation» is Go to section Settings → Battery
indicator is not working
switched on preservation
Remote electrode is
7) The device does connected to the device, Disconnect remote electrode if you don’t
not shot down under the device is in the mode use it
absence of contact of «Therapy»
electrode with skin or
nonuse of buttons for Function «Forced therapy» is
more than 10 minutes Switch off function «Forced therapy»
switched on

8) The device switches

off or symbol of battery
Voltage of batteries is less Change batteries ( see section «Method of
flashes and the device
than 2,1V replacement of batteries»)
emits discontinuous
signal
143
 9) The device does not Active reminders are absent Go to section «Alarm» and set reminders
switch on at the time
specified by the func- Voltage of batteries is less Change batteries ( see section «Method of
tion «Alarm» than 2,1 V replacement of batteries»)
10) The device switches Voltage of batteries is less Change batteries ( see section «Method of
off spontaneously than 2,1 V replacement of batteries»)
Use high-quality batteries (alkaline atteries
are recommended) or accumulators of
Off-grade batteries
corresponding unitsize with voltage of no
more than 1,5 V
11) «Quick consump-
Decrease level of brightness. Go to section
tion» of batteries Level of brightness is maximal
Settings → Display
Switch on function «Battery preservation».
Function «Battery
Go to section Settings → Battery
preservation» is switched off
preservation
Attention! Other troubles must be eliminated by the manufacturer or at the service
144
centers of the manufacturer.
11. MANUFACTURER’S WARRANTY
11.1. Operating time of the device — 5 years.
Under observance of operation regulations actual operation time can significantly exceed
official one.
11.2. Warranty period for the device is 24 months from the date of sale.
11.3. The seller (manufacturer) or organization which acts as a seller (manufacturer) on
the basis of contract with it is not responsible for the defaults should they occur after the
disposal of the device as a result of:
1) failure on the part of the consumer to comply with the rules of transportation, storage,
care and operation provided by the present manual;
2) mechanical damages;
3) actions of the third party;
4) force-majeure.
145
 11.4. Guarantee obligations do not apply to products with broken manufacturer’s seals.
11.6. In case of unit breakdown or malfunction within the warranty period, as well as in
case of incomplete shipping is found, the owner must send the following documents to the
manufacturer’s address or manufacturers’ representative: claim for repair (exchange) with
name, address, telephone number; defects list with brief description of the malfunction,
date and conditions of its appearance.

146
Address of Manufacturer:
«TRONITEK» LLC
Ekaterinburg, 620146, Russia
Akademika Postovskogo Str., 15
Tel.: +7 (343) 267-23-30
e-mail: corp@denascorp.ru
http://www.denascorp.ru

Official representative in EU countries:

DENAS-CZ s.r.o.
Na Výhledě 886/3a, 36017 Karlovy Vary
Czech Republik
Tel./Fax:+420 353 549 285
E-Mail: denas.cz@seznam.cz
www.denas-health.com
www.denasworld.com
 PART 2
Usage Instructions
 1. GENERAL PROVISIONS
Application of impulse currents on reflex zones and points for prophylaxis, treatment and
functional recovery is an independent method of treatment and can be applied both as a
complex treatment and as a mono therapy.
Numerous examinations show that the therapeutic action of the dynamic
electroneurostimulation (DENS) is based on multilevel reflex and neurochemical reactions
triggering a cascade of regulatory and adaptive mechanisms of the body. It results in
elimination of pain syndromes, improvement of blood circulation, anti- inflammatory
actions, activation of biologically active substances and metabolic processes in tissues,
normalization of the muscle and vascular tones. Dynamic electroneurostimulation promotes
improvement of general condition, better mood and capacity for work.

150
2. INDICATIONS AND CONTRAINDICATIONS FOR USE
The device DiaDENS-PCM can be applied to patients of any age from newborns to people
advanced age.
Indications:
— acute and chronic pain syndromes;
— traumas;
— respiratory diseases, diseases of the digestive device, diseases of ENT, blood circulation
system, musculoskeletal system, nervous system, endocrine and urogenital systems,
eyes, skin;
— rehabilitation after diseases, surgical operations and traumas;
— increasing body adaptive capacities under impact of negative pathogens factors,
intensive physical and mental work, physical and mental overexertion, syndrome of
chronic fatigue, difficulties with waking up in the morning and sleepiness during day-
time, disorders of falling asleep in the evening and insomnia, increased petulance, under
depressive states, sexual dysfunction, as well as for prophylaxis of colds. 151
 Contraindications:
Absolute:
— individual intolerance to the electric current;
— implanted cardiostimulator;
Relative*:
— epileptic seizures;
— neoplasms of any etiology and localization (in the terminal stage of an oncological
process, electrostimulation may be carried out as palliative method (supportive therapy),
including rapid relief of the pain syndrome, after consultation with a doctor);
— acute febrility of unclear etiology;
— vein thrombosis;
— condition of acute psychical excitement, alcoholic or drug intoxication.
Attention! Do not apply the device in the zone of direct heart projection at the front!
152 In these cases it is recommended to use the electrostimulator only after consulting your attending doctor.
3. CONDITIONS FOR TREATMENT
You do not need any special conditions for treatment with DENS. Treatment procedures can
be carried out both individually and with help of an operator who will carry out treatment
on those zones and points, which you cannot reach yourself.
Electrotherapy is taken in a comfortable sitting or lying position. After the treatment
procedure the patient should relax for 10-15 minutes.
The present manual describes treatment plans with most some widespread disease states.
More detailed information about DENS opportunities is provided in the Manual on Dynamic
Electroneurostimulation supplied with the devices DiaDENS-T and DiaDENS-DT*.
Attention! Treat the device electrodes with a standard disinfection means (such
as 3% solution of hydrogen peroxide) after each procedure. The electrodes of the
device should be kept dry.

* Manual on Dynamic Electroneurostimulation with Apparatuses DiaDENS-T and DiaDENS-DT // under general
edition of V.V. Chernyshev. – Ekaterinburg, 2005. 153
 4. INTENSITY (POWER) OF ELECTROSTIMULATION
The level of electrostimulation with impulse current is determined individually based on
subjective sensations of the patient. Intensity of electrostimulation is conditionally divided
into three levels.
The first minimal level - the patient does not have any subjective sensations or has subtle
vibrations in area of impact under electrodes. This level is used when treatment shall not be
intensive – for children up to 7 years old and patients with diseases of cardiovascular system
(hypertension, hypotension, a syndrome of vegetative-vascular dystonia). For patients who
are experiencing frequent headaches, dizziness treatment should also be carried out with
minimal power.
Second comfortable level — patient feels light pricking, vibration or light burning without
pain. It is used under treatment of weak pain and aches of medium intensity. This is the most
frequently used power level.
154
The third maximal level – the patient feels expressed painful pricking or burning. Such
intensity can be accompanied by involuntary contraction of muscles close to electrodes. It is
used under expressed pain syndrome.
Under switching on level of power is equal to zero. To increase power you should press
and hold button . Meanwhile, the power will be increased subsequently - from 0 to 99
conditional units.
To decrease power you should press and hold button . Meanwhile, the power will be
decreased subsequently.
Attention! Power of electrostimulation can be increased or reduced during the
treatment course depending on the extent of the patient’s sensitivity and as the pain
syndrome reduces.
Attention! Control of power level is executed subjectively considering sensations of
patient. You shall not exceed pain threshold.
155
 Attention! For patients with hypertension, hypotension, a syndrome of vegetative-
vascular dystonia as well as patients who have frequent headaches, dizziness,
treatment should be carried out with minimal power level.

156
5. Modalities
Dynamic electroneurostimulation with DiaDENS-PCM device is applied using three methods:
stabile, labile and labile-stabile.
Stable method of application (fixed electrodes) is used for treating small zones and on places
with mutated skin (rash, abscesses, burns, postoperative and post burn scars, edemas, large
birthmarks and so on).
With labile method of application the built-in electrodes are moved smoothly within
the application zone without taking them off the skin at 0,5-2-3 cm/sec. Movements are
rectilinear, spiral, circular and other depending on the size and shape of the zone treated
and on uninjured skin.
Labile-stabile method is a combination of both variants of treatment when electrodes are
moved on skin with fixation on some places (e.g. on the zone of maximal painfulness).
157
 Average duration of one treatment procedure:
— for children of the first year of life — 5-10 minutes;
— for children of 1-3 years — 10-15 minutes;
— for children of 3-5 years — 15-20 minutes;
— for children of 5-12 years — 20-25 minutes;
— for children of more than 12 years and adults — up to 40 minutes.
It is recommended to treat no more than three zones in one treatment procedure.

158
6. TREATMENT WITH THE DEVICE
Exposure in modes «Express» and «Therapy» is applied under localized pain syndromes,
functional disorders, for emergency aid. The duration of the procedure in the therapy mode
in the zone of direct projection of pain and functional disorder is defined by the following
reactions of the patient:
— the complaint is fully removed;
— the patient feel considerable improvement of the state of health;
— the patient has fallen asleep.
Power level of treatment in the THERAPY mode: from minimal to maximal. Methods of
treatment of a skin zone: stabile, labile, labile-stabile.
6.1. Use of the device by universal methods
MENU → Treatment → «Express» → Select program
Select necessary symptom or disease to be treated from the list.
159
 Press the electrodes to skin on the selected zone of treatment (schemes of treatment in
«Express» mode are given is Appendix 2. Set the power of treatment.

Attention! Control of power level is executed subjectively, considering sensations of

patient. You shall not exceed pain threshold.

On switching on the device power value is equal to zero. To increase power of treatment
press and hold button . The power will subsequently increase from 00 to 99 conditional
units. To reduce power of treatment press and hold button . The power will be decreased
subsequently.
After setting of power of treatment countdown of time of impact will start. The time is
counted downward (indicating the time remaining until the end of stimulation of the zone).
At the end of stimulation of zone alarm tells you when to rearrange the electrode to the next
area of impact. Methods of treatment in «Express» mode are given is Appendix 2.
160
6.2. Individual selection of operation modes. In the «Therapy» mode the following
frequencies are available:
6.2.1. Therapeutic frequency 200 Hz
MENU → Treatment → «Therapy» → 200 Hz
200 Hz — is a super high frequency. It is applied in the zone of direct projection of
the complaint. The effect is achieved during several first minutes and continues from
several minutes up to one hour. To increase the duration of the effect after analgesia the
device treatment can be continued at low or high frequencies.
Indications: acute pains associated with diseases and affection of musculoskeletal
system during the acute period and pathology of the peripheral nervous system.
6.2.2. Therapeutic frequencies 60, 77 and 140 Hz
MENU → Treatment → «Therapy» → 60 Hz
MENU → Treatment → «Therapy» → 77 Hz
161
 MENU → Treatment → «Therapy» → 140 Hz
60, 77 and 140 Hz — are high-frequency range. They are applied in the zone of direct
projection of the complaint and segmental zones . The effect is achieved in 5-10 minutes
after the start of the procedure and continues up to one hour and longer.
Indications: inflammatory and functional diseases of internal organs with moderate
pain syndromes, blood circulation disorder.
6.2.3. Therapeutic frequencies 10, 20 Hz
MENU → Treatment → «Therapy» → 10 Hz
MENU → Treatment → «Therapy» → 20 Hz
10, 20 Hz — are low frequencies. They are applied in the zone of direct projection of
the complaint, general zones and zones which enhance system effect. The effect is
achieved after 20-60 minutes and continues from several hours and longer.
Indications: diseases of internal organs, musculoskeletal system including traumas
162 (subacute and remote periods), postoperative period.
 6.2.4. Infra-low frequencies
MENU → Treatment → «Therapy» → 9,9Hz...1,0Hz (increment - 0,1 Hz)
Infra-low frequencies are selected by following chart:
Frequency, Hz Pathology*
1,2 Autoimmune diseases, tachycardia, weakness in knee joints
1,6 Arthritis-arthrosis
Acne, abscess, hypotension, dermatitis, parodontosis, sympathicotonic action,
1,7
furunculosis, eczema
2,2 Fatigue, pustular eczema
Sleepiness, vegetative disorders, hypermenorrhea, headache, associated with
diseases of paranasal sinus, hemorrhages, contusion, traumas, menorrhagia,
2,5
hystero- myoma, edemas, toxic and infection liver injuries, hepatitis, cirrhosis,
parodontosis, sinusitis, injuries, eczema
Samohin A.V., Gotovski Y.V. Electroacupuncture diagnostics by method of R. Foll .- Moscow: Center of intellectual
medical systems «IMEDIS «, 2003.- 512 pages. 163
 Viral syndrome, hemorrhoids, headaches under liver diseases, intestinal headaches,
2,6
dermatit is,impotence
2,8 Nephritis, nephrolithiasis, renal colic, renal sclerosis, uremia
2,9 Rhinitis, sinusitis
Arteriosclerosis, hypertension, otosclerosis, toxic and infection liver injuries (hepatitis,
3,3 cirrhosis), nephrolithiasis, renal colic, renal sclerosis, uremia, nephritis, furunculosis,
hypertension associated with atherosclerosis
3,5 Cholelithiasis, nephrolithiasis, renal colic, weakness in knee joints, menorrhagia
3,6 Inflammation, grizzle, petulance
3,8 Allergy, hemorrhoids, spasms of different genesis
3,9 Neuralgias, sleep disorders (phase of falling asleep)
Adiposogenital dystrophy (obesity), asthma, viral syndrome, hemorrhoids, hypermen-
4,0 orrhea, endocrine headache, vertigo, hypophysial disorders, impotence, climax,
menorrhagia, pancreatogenous disorders
164
4,6 Parathyroid gland dysfunction (calcium balance affection)
Viral syndrome, menage headache, climax, menorrhagia, obesity, rigid neck, furuncu-
4,9
losis, menologies
5,5 Vascular headache
5,8 Otogenic headache, depressions
5,9 Spastic paralysis
Hypertension, headaches associated with liver diseases, rigid neck, extrasystole, systolic
6,0
hypertension, increase capacity for work
Headaches associated with cerebral angiospasms, neuroses, petulance, cerebral
6,3
contusion
6,8 Myalgias, muscle cramps
7,5 Trifacial neuralgia
7,7 Spastic paralysis
8,0 Headache of intestinal genesis, asthma, allergic bronchitis
165
 Diuretic action (including for balance of potassium and sodium, nephrolithiasis,
8,1
renal colic, nephritis, cystitis (pyelocystitis)
8,5 Insomnia
8,6 Fractures, duodenal ulcer
Hypertension, otogenic headache, nephrogenic headache, podagra, diastolic
9,2 hypertension, dermatitis, spastic paralysis, renal sclerosis, uremia, furunculosis,
eczema (including combined with renal disorders), diabetes mellitus
9,3 Flaccid paralysis
Adnexitis, obstructive bronchitis, hypertension, gastrogenic headache, intestinal
headache, urogenital headache, endocrine headache, duodenitis, impotence,
9,4 edemas, paresthesias, pareses, prostatitis, angina pectoris, erythema nodosum,
furunculosis, cystitis (pyelocystitis), eczema, parametritis, gastric ulcer, ulcero-
necrotic endomyocarditis
Hypertension, headache of vascular genesis, climacteric hypertension, laryngitis,
9,5
parodontosis
166
9,6 Arthritis-arthrosis, spondylitis deformans, depressions, spinal injuries, osteochondrosis
9,7 Arthritis-arthrosis, lumbosacral radiculitis, podagra, renal sclerosis, uremia, rheumatism
9,8 Toxic and infection liver injuries, hepatitis, cirrhosis

6.2.5. Mode «77 10»

MENU → Treatment → «Therapy» → 77 10
7710 mode is intended for general sedative calming effect. Level of power - minimal or
comfortable. Method of application - stabile.
6.2.6. Mode «77 AM»
MENU → Treatment → «Therapy» → 77 AM
Mode 77 AM is intended for general restorative effect, better mood and capacity for
work. Level of power - minimal or comfortable. Method of application - stabile.

167
 6.3. Program of minimum effective dose (PROPHYLAXIS)
MENU → Treatment → MED
The MED* mode (PROPHYLAXIS) is applied in cases of expected intensive physical and
mental work, physical and mental overexertion, syndrome of chronic fatigue, difficulties
with waking up in the morning and sleepiness during the day-time, inability to concentrate
one’s attention, for prophylaxis of colds during epidemics. It is applied once during the
treatment procedure. It is recommended to apply as course treatment: 8-12 procedures.
Fix electrodes of the device to the zone he-gu. Set power
of treatment. Level of power to be applied is minimal or
comfortable.

168 MED — minimum effective dose.

 Attention! Control of power level is executed subjectively considering sensations
of patient under contact of electrodes with skin surface. You shall not exceed pain
threshold.
Under detection of contact of electrodes of the device with skin surface countdown of
period of minimum effective dose of device’ impact will start.
Under switching on of the device power value is equal to zero. To increase power you should
press and hold button . Meanwhile, the power will be increased subsequently - from 0 to
99 conditional units.
To decrease power you should press and hold button . Meanwhile, the power will be
decreased subsequently.
Attention! During the device operation in «MED» mode electrodes on the patient’s
skin should be set in the «stabile» position, i.e. they should not move.
169
 After the end of the program, sound signal will be generated. In average, program works
6-7 minutes.

6.4. Mode «Screening »

«SCREENING» mode allows: to select most optimal zones for impact to enhance system
effect of DENS, to determine latent trigger zones (hidden problem zones) by estimation of
the skin electrical resistance increase to nearby areas of the chosen zone.
MENU → Treatment → «Screening»
Put the electrodes of the device to the chosen skin zone. Frequency (10 Hz) and power of
impact are automatically set by the device.
Attention! During the device operation in «Screening» mode electrodes on the
patient’s skin should be set in the «stabile» position, i.e. they should not move during
operation in mode «Screening».
170
When the device detects the contact between the electrodes and skin surface indication of
period of time will appear – 5 seconds during which skin electrical resistance is determined,
after the impulse is sent by the device. After 5 seconds interval the device will emit short
sound signal and the display will show the measurement result as a ΔLT index (in range from
0 to 100 units), e.g., ΔLT = 8.
Write down the readings. Set the device to the next zone.
The latent trigger zones are those zones where ΔLT values significantly differ – upwards or
downwards. For example, under test of nearby areas you get following ΔLT results (in units):
6, 5, 8, 20, 4, 7. In this case the zone with the index ΔLT = 20 is considered to be latent trigger
one.
Detected trigger zones should be additionally treated in «THERAPY» mode for 1-5 minute at
60 or 77 Hz frequency. Go to menu:
MENU → Treatment → «Therapy» → 60 Hz
171
or
MENU → Treatment → «Therapy» → 77 Hz
Put the electrodes of the device on the trigger zone and apply treatment.